Last updated: 11/07/2018 11:12:45
Administrative Database Study on the Impact of Adherence to Drug Therapy in Asthma Patients Treated with ADVAIR or Fluticasone Propionate in Quebec
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Administrative Database Study on the Impact of Adherence to Drug Therapy in Asthma Patients Treated with ADVAIR or Fluticasone Propionate in Quebec
Trial description: This is a retospective observational study that will utilize pharmaceutical and medical claims from the Quebec Provincial Health Insurance administrative databases. All patients with a diagnosis of asthma that have been treated with fluticasone propionate/salmeterol combination or fluticasone propionate monotherapy between January 01, 2001 and March 31, 2011 will be included in the asthma cohort. Patients will be followed from the time of entry in the cohort through March 31, 2011, death or withdrawal from the insurance plan whichever occurs first. The study assesses the association between adherence to treatment and asthma related health care resource utilization in patients treated with fluticasone propionate/salmeterol combination in a single inhaler (FSC). Adherence to treatment will be determined on the basis of the Medication Possession Ratio and Persistence. Exacerbations will be defined as use of oral corticosteroids, emergency room visits and hospitalizations related to asthma. Health care utilization will include medication use, visits to physicians and clinics and hospitalizations
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Asthma-related healthcare resource utilization
Timeframe: January 01, 2001 to March 31, 2011
Asthma-related exacerbations
Timeframe: January 01, 2001 to March 31, 2011
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
0
Primary completion date:
Not applicable
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Afisi Ismaila, Diane Corriveau, Julie Vaillancourt, Daria Parsons, Richard Stanford, Zhen Su, John Sampalis.Impact of adherence to treatment with fluticasone propionate / salmeterol in asthma patients.Curr Med Res Opin.2014;30(7):1417-25
Afisi Ismaila, Diane Corriveau, Julie Vaillancourt, Daria Parsons, Richard Stanford, Zhen Su, John Sampalis.Impact of adherence to treatment with fluticasone propionate / salmeterol in asthma patients.Curr Med Res Opin.2014
Medical condition
Asthma
Product
fluticasone propionate, fluticasone propionate/salmeterol/norflurane, norflurane, salmeterol
Collaborators
Not applicable
Study date(s)
November 2012 to December 2012
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
none
- Patients will be selected by identifying all those in the database who had at least one medical claim with a diagnosis of asthma (ICD-9: 493.0, 493.1, 493.9, 493.8, 493.82) between January 01, 2001 and March 31, 2011. To be included in the study, patients will also have to meet all of the following criteria:
- i. To be at least 12 years old at the time of treatment initiation, defined as the first asthma prescription filled during the cohort inception period of the study (from January 01, 2001 to March 31, 2011);
- i. One or more medical claims with a diagnosis of Chronic Bronchitis (ICD-9: 490.xx, 491.xx) COPD (ICD-9: 496.xx) or Emphysema (ICD-9: 492.xx) between January 01, 2001 and March 31, 2011;
- ii. One or more medical claims with a diagnosis of respiratory tract cancer (ICD-9: 160.xx – 164.xx or 231.xx) between January 01, 2001 and March 31, 2011;
Inclusion and exclusion criteria
Inclusion criteria:
- Patients will be selected by identifying all those in the database who had at least one medical claim with a diagnosis of asthma (ICD-9: 493.0, 493.1, 493.9, 493.8, 493.82) between January 01, 2001 and March 31, 2011. To be included in the study, patients will also have to meet all of the following criteria: i. To be at least 12 years old at the time of treatment initiation, defined as the first asthma prescription filled during the cohort inception period of the study (from January 01, 2001 to March 31, 2011); ii. One or more pharmacy claim(s) for ADVAIR (fluticasone propionate / salmeterol) OR ≥ 1 pharmacy claims for fluticasone propionate.
Exclusion criteria:
- i. One or more medical claims with a diagnosis of Chronic Bronchitis (ICD-9: 490.xx, 491.xx) COPD (ICD-9: 496.xx) or Emphysema (ICD-9: 492.xx) between January 01, 2001 and March 31, 2011; ii. One or more medical claims with a diagnosis of respiratory tract cancer (ICD-9: 160.xx – 164.xx or 231.xx) between January 01, 2001 and March 31, 2011; iii. Any prescriptions for an inhaled anti-cholinergic, leukotriene receptor antagonist, inhaled mast-cell stabilizer, methylxanthine or IgE blocker between January 01, 2001 and March 31, 2011
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2012-11-12
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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